Sound Evidence for Your Peripheral Calcium Strategy

At Shockwave, we’re committed to the creation of sound clinical evidence to support the adoption and long-term utilization of our technology. This includes a balance of high-quality Shockwave-sponsored and investigator-initiated research studies to advance the knowledge of our technology’s performance in daily practice.

Shockwave's Clinical Evidence Pillars

What We Set Out to Demonstrate

Safety

Consistent safety profile across studies for the patient and within the vessel

Effectiveness

Highly effective in dilating calcified lesions – from the simple to the complex

Value

Economic value through the reduction of complications and cost escalation

Ease of Use

Seamless integration with consistent outcomes and no learning curve, regardless of skill level

Shockwave-sponsored DISRUPT PAD Clinical Program

Single-arm, pre-market European study demonstrating the safety and performance of IVL as standalone therapy in heavily calcified, fem-pop lesions and followed to 6 months.

A prospective, randomized, multicenter, study to evaluate the benefit of IVL combined with drug-coated balloons vs standalone DCB in heavily calcified fem-pop lesions followed out to 24 months. It is also includes an all-comers registry arm to assess the real-world acute performance of IVL in lower extremities, including iliac, femoral, fem-pop, popliteal infrapopliteal lesions.

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We're excited about IVL's potential in aortic stenosis, too!

But, right now we're in the early phases of the R&D program. In the meantime, don't miss the IVL application that heart teams are embracing already — maintaining transfemoral TAVR access through heavily calcified iliacs by using IVL.

Get Crackin with Shockwave IVL Today

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Wow - you're ready to start cracking, aren't you?

Too bad our coronary technology is not yet approved in the United States. Good news is that we have initiated our U.S. FDA IDE study. Learn more about the Disrupt CAD III study on our clinical research portion of the website.